In the pharmaceutical industry, simplicity leads to the most effective solutions. In a sector where the stakes are as high as life and death, packaging is focused on functionality and communication.
Most of us tend to associate “design” with curves, ornamentation and colours. As design emerges from art, it is natural that we expect its most evocative expression to be full of aesthetic imagery, or in plain words, simply “sexy.” Centuries of artistic tradition, across art related fields, such as architecture, visual arts and product styling have led to the evolution of art forms that have been labeled with terms like art deco, functional or minimalist. “The term ‘minimalist’ is often applied colloquially to designate anything which is spare or stripped to its essentials. It has also been used to describe the plays of Samuel Beckett, the films of Robert Bres- son, the stories of Raymond Carver, and even the automobile designs of Colin Chap- man.” (Wikipedia)
In packaging these days, the designer’s preoccupation with curves tends to be even more obsessive. (Perhaps increasingly due to the relative ease of visualisation of complex, curvaceous shapes enabled by modern 3D software. (See Packaging South Asia No. 1/07 “Towards Zero Degree of Packaging”) The shop shelves around us are crowded with bottles and packs that are bent, slanted and curved in all possible ways; hunchback bottles, pebble-shape bottles, slant mouth bottles and sexy curve bottles. No doubt, this is the designer’s way of attracting customer attention to the brand and breaking out of the clutter on the shelf. Even if this effort at differentiation, places more demands on the tooling costs and end-of-line packing machines required, the potential increase in sales makes it justifiable.
However, when design for medical packaging is involved, the situation changes drastically. Most people never think of packaging as a life-or-death proposition, but for companies that handle the intricate and complex business of pharmaceutical packaging, that’s exactly what’s at stake. Under such circumstances, form gives way to functionality and colours give way to communication. “Production constraints determine the course of the design development,” observes Mr Subodh Gupta, Managing Director, Triveni Polymers — who have pioneered production of FDA approved pharma bottles in the country. “Issues like efficiency of filling, capping, labeling, puck handling etc. dominate the thinking. It is for such reasons that simple, cylindrical bottles are preferred instead of, for example, square base bottles which are problematic to pro- duce and label efficiently.”
Quality first and last
“We are committed to a program of con- tinuous quality improvement in order to meet the requirements of customers, reg- ulatory bodies, associates as well as the environment. This imposes a responsi- bility of recognising the real needs of customers and ensuring compliance at every level, again and again. All our manufacturing facilities and our policies and pro- cedures are governed by current Good Manufacturing Practices (cGMPs). These are formally audited four times a year and all issues that may arise are closed through Corrective and Preventive Action Measures (CAPA) ” says the, Triveni web- site (www.trivenipolymers.com).
Another leading producer of PET bottles for the pharma industry continues in the same vein: “Aiming to serve the emerging needs of the pharma industry for PET bottles, we have set up facilities at Daman, Baddi and Roorkee for production, strictly under Class 10,000 clean room conditions, on single-stage ISBM machines” (www.alpha.in)
It’s a tall order, with an absolute requirement for quality that incorporates a zero tolerance for error, rework, and extra production costs associated with incorrect bar coding and legal, product-ingredient, or product-use text. The process is made all the more challenging by the need for distributed collaboration among a staggering array of supply-chain partners. These can include graphic and structural designers, print- ers, converters, finishers, die makers, legal and editorial departments, marketing and product development teams and others.
Evidently, all aspects of packaging for the pharma industry are, therefore, so tightly controlled that it leaves little room for “creative design.” Food & Drug Administration (FDA) policies govern the content, format, and placement of pharmaceutical labels. Accurate, user-friendly placement of copy and graphics, as mandated by the FDA, requires that certain information appears in a specified sequence, making it easier for healthcare professionals and consumers to use the information without making dis- pensing or usage mistakes.
Needless to say, the extra steps that must be taken in conforming to quality standards have the potential to quickly escalate the cost and extend the time it takes to ready a pharmaceutical package for market. This places an enormous burden on converters, who are charged with the responsibility to cut costs, wastage and labour from the process and deliver the product on an accelerated schedule.
Essentials of clinical pack design
The critical need for combining production efficiency with zero tolerance for error suggests the following “essentials” within which clinical packs need to be designed and developed:
In order to produce a successful package design, the packaging system must be well defined. The packaging engineer/designer must collaborate with project team mem- bers to create a “packaging design requirements” document that provides a clear expectation of the function, limitations, special features, aesthetics, product/company branding, cost limitations, size limitations, sterilisation method, labeling requirements, hospital/clinic storage requirements, case count and possible adverse conditions of use and/or distribution and storage.
As medications become more potent and potentially more toxic, packaging must provide different levels of security. This is a tough balancing act, yet one that manufacturers are diligently addressing. Amongst these issues is the very real need for two opposing requirements that must be met; packages must be hard to open to meet Child Resistant (CR) standards, and yet they must be easy to open to be considered Senior-Friendly (SF). In other words, clinical packs must be safe when closed and easily accessible when they need to be opened.
Constraints imposed by the various Drug Authorities across the world govern the use and description of drug and biological products. This can add layers of complexity. Intense competition for market share among pharmaceutical manufacturers places a premium on time-to-market and magnifies the pressure on the converter.
A packaging system hazard analysis is recommended at an early stage, once the package design requirements have been established and then moved through the next few essential activities of defining the clinical storage, handling and use environments as well as the distribution and handling environments so that the decisive activity of pro- totyping the packaging system can begin.
Selection of materials to be used for the packaging is critical at this stage and must be rigorously tested to ensure compliance with laid down standards for compatibility, non-toxicity, environmental stress resistance, trace elements and barrier properties.
Today’s increasingly complex medical packaging needs require the designer to per- form a thorough investigation of the anticipated distribution, storage and handling con- ditions. Clinical trial packages require focused attention, as frequent shipping, stor- age and handling activities contain exceptions such as prolonged storage at temper- ature extremes at small clinical settings.
Clinical packaging is occasionally carried in luggage by patients or medical profes- sionals. Perhaps the pack is temperature-sensitive and requires thermal insulation. What is the temperature profile of the seasonal shipping event as well as the device tem- perature and humidity stability range?
A package performance and seal integrity test is used to refine the package system design for maintenance of sterile barrier integrity and to deliver a safe and effective clinical pack. Feasibility tests, package system performance tests or a notebook study are conducted to make an informed risk assessment.
A few examples of the type of tests that need to be conducted to ensure pack integrity are:
- Conditioning of packaging materials, packages: American Society for Testing and Materials ASTM D4332:2001.
- Performance testing: ASTM D4169:2005 — Practice for performance testing of shipping containers, ISTA 1, 2, 3 Series International Safe Transit Assn. Preshipment Test Procedures.
- Package Integrity (porous packages): ASTM F1929:1998 — Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
- Package Integrity (internal pressurisation): ASTM F2096:2004 — Standard test method for detecting gross leaks in porous medical packaging by internal pressurization (bubble test).
- Seal Strength: ASTM F88:07a — Standard test method for seal strength of flexible barrier materials.
- Visual Inspection: ASTM F1886-98 — Standard test method for determining integrity of seals for medical packaging by visual inspection.TcGMP (Current Good Manufacturing Practices)Continuing with the Triveni Polymers website shows, for example, that “The documentation that is available is in line with cGMP requirements, as applicable in the pharmaceutical industry and has been audited and certified by several leading finished formulation pharmaceutical exporting companies from India. All personnel are trained on various aspects of cGMP on a continuous basis to make them constantly aware of cGMP requirements and be updated, if needed.” This is indicative of the vital importance of the cGMP aspect of the development and all efforts are made to ensure that the packs being developed are capable of meeting the criteria.
Clearly, clinical pack design and development offer a set of challenges that demand close scrutiny and attention to detail that can mean the difference between form and function or the difference between life and death. Some of these issues can be summarized as:
- Labelling for product identification, directions for use, bar coding and inventory management requirements.
- Examination of existing storage systems for integration.
- Ease of use of package/device.
- Package size as it relates to storage and use.
- Packaging materials utilised (primary, secondary and tertiary packaging systems)
- Is it imperative that the package be see-through and why?
- Does the primary sterile barrier package impede removal and aseptic technique?
- Does the package facilitate one-handed opening and removal?
- If the device is a procedural kit, are all the expected and necessary components contained within the kit package?
Streamlining the work-flow
Most people in the industry would agree that amongst the biggest hazards facing a clinical pack design team is the management of a successful and efficient label art- work design process. Ensuring that the design fulfills the requirements of the protocol, meets the need of the project team and meets the expectations of the medical pro- fessionals is a critical goal for the successful and efficient design process. A process that relies on paper sketches, office program clip art, verbal descriptions or other suboptimal ways to build and depict package designs can suffer from shortcomings in quality of communication.
Proofreading pharmaceutical copy presents its own special challenges, such as the use of nonstandard fonts, special characters and symbols. It may appear that a decimal point would not matter, but if you miss one you may also have given the patient 10 times the recommended dosage. It is for such reasons that while “soft copy” processes are popular elsewhere, the pharma industry still relies on the dependabil- ity of “hard copy” proofs. As one industry executive puts it, “When the price of a print- ing error could be as high as going out of business for a pharmaceutical manufacturer, maintaining accuracy in the art working work-flow process is a huge concern.” The good news is that specialized groups around the world are working overtime to address these very challenges and offer streamlined systems like “virtual prototyping” or “complete packaging, individual solutions.” (See www.nosco.com; www.esko.com. )
In conclusion, the discipline demanded by clinical pack design helps to underline the old design adage that “less can sometimes be more”. Could the future of all pack- aging, be it food, drink or cosmetics, lie in getting back to the design basics? Simple can be seductive and that’s pure design minus the nonsense!